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PET/MR Assessment of Sipuleucel T Treatment for Metastatic Castration Resistant Prostate Cancer

Primary Purpose

Prostate Cancer

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PET/CT
PET/MRI
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Prostate Cancer focused on measuring imaging, diagnostic, castration resistant, metastatic prostate cancer, immunotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Men ≥ 18 years of age
  • History of prostate cancer treated with androgen deprivation
  • Serum Testosterone levels <50 ng/mL
  • Established asymptomatic or minimally symptomatic metastasis
  • Eastern Cooperative Oncology Group (ECOG) performance status≤2
  • Accept the terms of the imaging modalities and performance at pre-established time points as described in the protocol and consent
  • Accept the terms for immune-monitoring blood drawing and performance at pre-established time points as described in the protocol and consent
  • Patients that are on steroids (prednisone up to 10mg daily or hydrocortisone 20 mg daily) alone or in combination with Zytega or ketoconazole prior to enrollment are eligible
  • Patients that are on steroids for an underlying chronic condition are eligible. (prednisone up to 10 mg daily, dexamethasone <2 mg daily or fludrocortisone 0.1 mg daily orally)

Exclusion Criteria:

  • Chemotherapy or radiation therapy treatment within 21 days of Sipuleucel-T
  • ECOG performance status >2
  • Prior treatment with Sipuleucel-T
  • Patients with a history of another primary malignancy within the last 2 years that was not curatively treated, excluding basal or squamous cell carcinoma of the skin
  • Patients with known positivity for human immunodeficiency virus (HIV) or hepatitis C; baseline testing for HIV and hepatitis C is not required
  • Patients with any significant history of non-compliance to medical regimens or with inability to grant a reliable informed consent
  • Active spinal cord compression.

Sites / Locations

  • New York University Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PET/MR

Arm Description

Patients treated with SipT (standard of care) undergo FDG-PET/MRI, NaF-PET/CT and blood drawing at 3 time points: baseline, Day 7 after the last SipT infusion, Week 10 after the last SipT infusion.

Outcomes

Primary Outcome Measures

Percentage of patients with imaging parameter change(s) among the patients with immunological response
NaF-PET/CT, FDG-PET/MRI, and blood drawing (for immunological response) are performed on patients at baseline, day 7 after the last SipT infusion, and week 10 after the last SipT infusion. The changes in SUV (standard uptake value) max on FDG-PET and NaF-PET, in MRI-ADC (apparent diffusion coefficient ) value, in MRI contrast enhancement, and in T2 lesion size will be measured.

Secondary Outcome Measures

Percentage of patients with imaging parameter change(s) among the patients who respond per Response Evaluation Criteria In Solid Tumors (RECIST)
NaF-PET/CT, FDG-PET/MRI, and blood drawing (for immunological response) are performed on patients at baseline, day 7 after the last SipT infusion, and week 10 after the last SipT infusion. The changes in SUV max on FDG-PET and NaF-PET, in MRI-ADC value, in MRI contrast enhancement, and in T2 lesion size will be measured.

Full Information

First Posted
January 17, 2014
Last Updated
July 13, 2017
Sponsor
NYU Langone Health
Collaborators
Dendreon
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1. Study Identification

Unique Protocol Identification Number
NCT02042053
Brief Title
PET/MR Assessment of Sipuleucel T Treatment for Metastatic Castration Resistant Prostate Cancer
Official Title
Multimodality Imaging Assessment of Sipuleucel T Treatment and in Vivo Immune Response of Metastatic Castration Resistant Prostate Cancer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Terminated
Why Stopped
Due to PI leaving the institution
Study Start Date
January 2014 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
Collaborators
Dendreon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study intents to provide an initial evaluation of the utility of positron emission tomography and magnetic resonance (PET/MR) imaging measures for the prediction of immunological response to Sipuleucel T (SipT) therapy.
Detailed Description
Recent studies of treatments of prostate cancer through stimulation of adaptive immune response have indicated the linear measurements by computed tomography (CT) and nuclear scans used to assess tumor response by Response Evaluation Criteria in Solid Tumors (RECIST) were inadequate and the value of progression-free survival (PFS) as a predictive surrogate endpoint of survival was lost. The objective of this study is to provide an initial evaluation of the utility of PET/MR imaging measures for the prediction of immunological response to SipT therapy. Investigators expect to identify an"imaging-signature" of response to SipT based on changes in metabolism, perfusion, oxygenation and cellularity of metastasis and its correlation with immunological and clinical response. This approach will help elucidate the mechanism of activity and dynamics of immune antitumor responses to SipT in vivo and to identify new parameters of tumor response and predictive value than current RECIST and PFS standards.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
imaging, diagnostic, castration resistant, metastatic prostate cancer, immunotherapy

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PET/MR
Arm Type
Experimental
Arm Description
Patients treated with SipT (standard of care) undergo FDG-PET/MRI, NaF-PET/CT and blood drawing at 3 time points: baseline, Day 7 after the last SipT infusion, Week 10 after the last SipT infusion.
Intervention Type
Device
Intervention Name(s)
PET/CT
Intervention Type
Device
Intervention Name(s)
PET/MRI
Primary Outcome Measure Information:
Title
Percentage of patients with imaging parameter change(s) among the patients with immunological response
Description
NaF-PET/CT, FDG-PET/MRI, and blood drawing (for immunological response) are performed on patients at baseline, day 7 after the last SipT infusion, and week 10 after the last SipT infusion. The changes in SUV (standard uptake value) max on FDG-PET and NaF-PET, in MRI-ADC (apparent diffusion coefficient ) value, in MRI contrast enhancement, and in T2 lesion size will be measured.
Time Frame
up to 14 weeks
Secondary Outcome Measure Information:
Title
Percentage of patients with imaging parameter change(s) among the patients who respond per Response Evaluation Criteria In Solid Tumors (RECIST)
Description
NaF-PET/CT, FDG-PET/MRI, and blood drawing (for immunological response) are performed on patients at baseline, day 7 after the last SipT infusion, and week 10 after the last SipT infusion. The changes in SUV max on FDG-PET and NaF-PET, in MRI-ADC value, in MRI contrast enhancement, and in T2 lesion size will be measured.
Time Frame
up to 14 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Men ≥ 18 years of age History of prostate cancer treated with androgen deprivation Serum Testosterone levels <50 ng/mL Established asymptomatic or minimally symptomatic metastasis Eastern Cooperative Oncology Group (ECOG) performance status≤2 Accept the terms of the imaging modalities and performance at pre-established time points as described in the protocol and consent Accept the terms for immune-monitoring blood drawing and performance at pre-established time points as described in the protocol and consent Patients that are on steroids (prednisone up to 10mg daily or hydrocortisone 20 mg daily) alone or in combination with Zytega or ketoconazole prior to enrollment are eligible Patients that are on steroids for an underlying chronic condition are eligible. (prednisone up to 10 mg daily, dexamethasone <2 mg daily or fludrocortisone 0.1 mg daily orally) Exclusion Criteria: Chemotherapy or radiation therapy treatment within 21 days of Sipuleucel-T ECOG performance status >2 Prior treatment with Sipuleucel-T Patients with a history of another primary malignancy within the last 2 years that was not curatively treated, excluding basal or squamous cell carcinoma of the skin Patients with known positivity for human immunodeficiency virus (HIV) or hepatitis C; baseline testing for HIV and hepatitis C is not required Patients with any significant history of non-compliance to medical regimens or with inability to grant a reliable informed consent Active spinal cord compression.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anna Ferrari, MD
Organizational Affiliation
New York University Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States

12. IPD Sharing Statement

Learn more about this trial

PET/MR Assessment of Sipuleucel T Treatment for Metastatic Castration Resistant Prostate Cancer

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